Panel Votes Positively on Safety, Efficacy and Risk/Benefit Ratio
Cartiva, Inc., (Company) a developer of innovative products for the treatment of cartilage injuries, osteoarthritis and other musculoskeletal conditions, announced today that the Orthopaedic and Rehabilitation Devices Panel convened by the U.S. Food and Drug Administration (FDA) voted 10 to two in favor of the safety of the Company’s Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis at the base of the great toe, nine to three in favor of the efficacy of Cartiva SCI and eight to two, with two abstentions, that the benefits outweighed the risks. The panel made their recommendations based on the results from a 236-patient prospective and randomized clinical trial, the largest ever conducted for this condition.
The FDA is not bound by the panel’s recommendation, but will take it into consideration, among other things, when reviewing the Company’s Premarket Approval application (PMA). The Company expects a final decision on approval of the PMA later this year. If approved, Cartiva SCI will be the first synthetic cartilage device ever approved by the FDA and the first PMA for any product in the forefoot.
“We are extremely pleased with the positive results of the panel vote, which is one of the final milestones towards the commercialization of Cartiva in the United States,” said Timothy J. Patrick, president and CEO of the Company. “We thank the panel members for their insights and will continue to work with the FDA to make Cartiva SCI available to patients in the United States.”
Peter Pizzo, 770-754-3855
Chief Financial Officer